BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated.

The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.

A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine

The Difference in CD4 From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]

Change in mean CD4 from Baseline to Week 48.

The Change in Adherence to Study Treatment Arm From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]

Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.

Change in Quality of Life From Baseline to 48 Weeks of Study Treatment [ Time Frame: baseline and 48 weeks ] [ Designated as safety issue: No ]

Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.

Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931801

Locations

United States, Arizona

Spectrum Medical Group

Phoenix, Arizona, United States, 85012

United States, California

AIDS Healthcare Foundation

Los Angeles, California, United States, 90028

United States, Colorado

Denver Public Health

Denver, Colorado, United States, 80204

United States, District of Columbia

Whitman-Walker Clinic

Washington, District of Columbia, United States, 20009

United States, Florida

Orlando Immunology Center

Orlando, Florida, United States, 32803

Treasure Coast Infectious Disease Consultants

Vero Beach, Florida, United States, 32960

United States, Kansas

Christi Research

Wichita, Kansas, United States, 67214

United States, Massachusetts

Community Research Initiative of New England - Boston

Boston, Massachusetts, United States, 02215

United States, Texas

David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group

Dallas, Texas, United States, 75804

Sponsors and Collaborators

Community Research Initiative of New England

Bristol-Myers Squibb

Merck Sharp & Dohme Corp.

Investigators

Principal Investigator:

Calvin J Cohen, MD, MSc

Community Research Initiative

More Information

No publications provided

Responsible Party:

Cal Cohen, Director of Research, Community Research Initiative of New England